Kornimate/medical-research-clean huggingface dataset:
gestational diabetes: a cohort study

Conditions: Gestational Diabetes; Diabetes, Gestational; Diabetes Mellitus in Pregnancy; Diabetes Mellitus, Type 2

Summary: gestational diabetes (gdm) is the most common hormonal complication during pregnancy. its occurrence implies an increased risk of maternal and fetal complications and, therefore, its diagnosis and treatment are extremely important. since the adoption of the new diagnostic criteria proposed by the international association of diabetes and pregnancy study groups (iadpsg) in 2010, an increasing number of cases of mild hyperglycemia have demanded follow-up and treatment. the need and benefit of treatment in these cases of mild hyperglycemia has been discussed worldwide. women who have been diagnosed with gdm are at increased risk for type 2 dm in the years following gestation. other factors (such as lipid profile, obesity, adipokine dosage) may also be related to the repercussions of gdm on the maternal-fetal binomial, since gestations with satisfactory glycemic control can also present complications related to the disease and increased risk of type 2 dm in the long term. the present study aims to investigate factors associated with the need for insulin use, the occurrence of perinatal complications, nutritional status, physical activity and weight retention one year after delivery and the postpartum diagnosis of type 2 dm 10 years after delivery in women diagnosed with gdm according to the current criteria suggested by the iadpsg.


Eligibility criteria:
inclusion criteria: * single pregnancies * absence of glucose intolerance prior to gestation (defined by prior diagnosis of polycystic ovarian syndrome or fasting glycemia ≥100mg / dl or 2hr post-overload with 75g glucose ≥ 140mg / dl or glycated hemoglobin ≥ 5.7% previously to pregnancy) * absence of chronic use of glucocorticoids or antiretroviral drugs for hiv virus, given its diabetogenic effect and potential confounding * diagnosis of gdm according to diagnostic criteria proposed by the iadpsg, namely: initial fasting blood glucose ≥ 92mg / dl or oral glucose tolerance test of 75g with fasting ≥ 92mg / dl or after1h ≥ 180mg / dl or after 2h ≥ 153mg / dl * agreement with the informed consent term for patients who will be followed prospectively * agreement with the free and informed consent term for recall and reassessment of the patients identified in the retrospective analysis of the data exclusion criteria: * loss to follow up during pregnancy

Keywords: gestational diabetes type 2 dm after gdm
hereditary hepatorenal tyrosinemia natural history in egypt and the arab world (multicenter clinical study)

Conditions: Hereditary Tyrosinemia, Type I

Summary: the purpose of the registry/repository is to understand the natural history of tyrosinemia in our region and to provide a mechanism to store data and specimens to support the conduct of future research about hereditary tyrosinemia among the arabs.

the purpose of this study is to create an electronic registry of phenotypic, laboratory information, treatment and outcomes options for tyrosinemia type i. the registry is longitudinal in nature including retrospective clinical data from birth to the most recent encounter with all data entered in chronological fashion. the goals of this registry are the better understanding of the natural history and treatment outcomes of these patients and to determine/evaluate biochemical and clinical parameters for monitoring and prognosis of tyrosinemia type i.

Eligibility criteria:
inclusion criteria: 1. biochemical or molecular diagnosis of tyrosinemia type i. 2. examined/followed by one of the participating sites. 3. parental/guardian permission (informed consent) for participation. exclusion criteria: 1. diagnosis of tyrosinemia has been excluded. 2. not examined/followed by one of the participating sites. 3. unwilling to provide informed consent for participation.
endoscopic treatment of benign biliary strictures and cystic duct leakages with a novel biodegradable biliary stent

Conditions: Biliary Tract Diseases

Summary: patients with either post-cholecystectomy bile leak or benign biliary stricture are recruited for endoscopic insertion of a biodegradable biliary stent. a follow-up of 12 months with repeated serum samples and magnetic resonance imaging is scheduled. the primary end points are feasibility of endoscopic insertion with the novel implantation device and stricture or leak resolution as well as clinical treatment success.

benign biliary strictures (bbs) and post-cholecystectomy bile leaks have traditionally been treated endoscopically with plastic stents. in bbs, promising results of covered self-expanding metal stent use have been recently published. however, in both bbs and post-cholecystectomy bile leak the need of stent therapy is temporary and endoscopic stent exchange or removal is unavoidable. these two groups of patients may be the ones that would most obviously benefit from biodegradable (bd) biliary stents. studies of bd stents on animal models have shown excellent long term patency and safety both in biliary and pancreatic duct as well better outcome compared to plastic stents after post-cholecystectomy bile leak in an animal study. until recently, non-operative insertion of bd polydioxanone stent in human biliary tract has been possible only via percutaneous route. with the novel implantation device, the bd stents (braided, self-expanding polydioxanone stent, 8 x 40-60mm, ella, czech republic) may be used endoscopically during endoscopic retrograde cholangio-pancreatography (ercp). the hypothesis is that larger diameter and radial expansion strength provide at least similar treatment success as the current method of endoscopic insertion of plastic or covered self-expanding metal stents in bile leak and bbs, respectively. however, later stent exchange or removal is not necessary with bd stents.

Eligibility criteria:
inclusion criteria: * informed-consent patients with diagnosed or suspected post-cholecystectomy biliary leak or benign biliary stricture. exclusion criteria: * patients with contra-indications for magnetic resonance imaging (mri) or surgically altered gastro-duodenal anatomy (e.g. roux-y-loop) are excluded from the study.

Keywords: biodegradable stents, ercp
treatment with crizotinib single patient expanded access ind 134375

Conditions: Inflammatory Myofibroblastic Tumour

Summary: two year old male with a new diagnosis of inflammatory myofibroblastic tumour. the patient presented with 2 months of intermittent fever and 1-2 weeks of abdominal distention and constipation. an abdominal mass was palpable on exam and us concerning was for neoplasm of abdomen. treatment with crizotinib will be utilized to reduce the size of the lesion and create more optimal tissue plains between vital structures prior to attempted surgical resection would greatly reduce potential morbidity for this patient.


Eligibility criteria:
inclusion criteria: * this treatment plan is intended for the use of crizotinib in the treatment of a single patient with inflammatory myofibroblastic tumour exclusion criteria: * not applicable as expanded access only includes one patient
getting biased treatment study: how psychotherapy and antidepressants change brain activity in chronic depression

Conditions: Chronic Depression

Summary: the purpose of this study is to determine how psychotherapy and pharmacotherapy respectively change brain activity in patients suffering from chronic depression.


Eligibility criteria:
inclusion criteria: * chronic depression (double depression, chronic mde, mde with incomplete remission) * hamd-24\>20 exclusion criteria: * concurrent psychotherapy or psychopharmacotherapy * previous non-response to duloxetine * non-response to three antidepressants of two different groups given at adequate doses or non-response to two empirically tested forms of psychotherapy in the current depressive episode * serious psychiatric comorbidity * serious neurologic comorbidity * contraindications to duloxetine * contraindications to fmri

Keywords: depression duloxetine psychotherapy magnetic resonance imaging
fosamprenavir in pts with hepatic impairment

Conditions: Infection, Human Immunodeficiency Virus

Summary: apv10017 was a pharmacokinetic study that evaluated the pharmacokinetics, safety and tolerability of fosamprenavir/ritonavir (fpv/rtv) at reduced doses over 14 days in hiv-infected subjects with mild to moderate hepatic impairment (hi). based on these data, two new regimens have recently been approved by the emea and fda in these patient groups; fpv 700mg bid/rtv 100mg qd for those with mild hi (child-pugh score 4-6) and fpv 450mg bid/rtv 100mg qd for those with moderate hi (child pugh score 7-9). the committee for medicinal products for human use (chmp) has requested longer-term safety data among this hepatically impaired hiv-infected population who have received the recently updated fpv/rtv dosing regimens. an observational cohort study will be conducted using routinely collected data in three european hiv patient cohorts with a high proportion of hepatitis co-infected individuals. patients who received fpv/rtv will be followed to address the following objectives. primary: to assess the safety and tolerability of fpv/rtv-based art in subjects with mild to moderate hepatic impairment. secondary: a). to compare the safety and tolerability of fpv/rtv-based art in subjects with mild to moderate hepatic impairment when compared to fpv/rtv-based art in hepatitis b (hbv) or hepatitis c (hcv) co-infected subjects with normal hepatic function. b). to compare the safety and tolerability of fpv/rtv-based art to lopinavir/ritonavir lpv/rtv-based art in subjects with mild to moderate hepatic impairment.

patients were not recruited for nor enrolled in this study. this study is a retrospective observational study. data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. all diagnoses and treatment are recorded in the course of routine medical practice.

Eligibility criteria:
inclusion criteria: * hiv infected patients with or without hepatic impairment coinfected with hbv or hcv who started fpv/rtv-based therapy on or after january 1, 2008. the fpv/rtv exposed patients will be stratified into four groups for analysis (see interventions a-d for label/description above), according to their degree of baseline hepatic impairment, which will be defined according to fpv/rtv dose received (and apri score for interventions a and d). the lpv/rtv intervention group must have started this therapy at approved standard doses on or after january 1, 2008. exclusion criteria: * receipt of fpv/rtv or lpv/rtv within the year preceding the baseline visit.

Keywords: antiretroviral therapy hepatic impairment hiv
comparing the diagnostic efficiencies of ceus and eob-mri in patients with high risk of hcc

Conditions: Hepatocellular Cancer; Liver Cirrhoses; Diagnoses Disease

Summary: hcc is a serious threat to the health of people. accurate diagnosis of early hcc by imaging allows patients to obtain proper treatment. however, for lesions with diameters ≤2 cm, the tumor blood supply is not fully established, and there may be no typical manifestation on the image. in addition, atypical enhanced patterns caused by liver cirrhosis may also hinder imaging diagnosis of hcc. therefore, early diagnosis of hcc in the context of cirrhosis remains a major clinical problem. contrast-enhanced ultrasound (ceus) and mri contrast-enhanced magnetic resonance imaging (cemri) are common diagnostic imaging methods. till now, there is still lack of a detailed investigation comparing the diagnostic efficacies of ceus and eob-mri for micro hcc in the context of cirrhosis. therefore, this study aims to analyze the imaging patterns in ceus and eob-mri for liver lesions with diameters ≤ 2 cm among patients with high risk of hcc, and to compare the diagnostic efficacies of eob-mri and ceus for early-stage hccs.


Eligibility criteria:
inclusion criteria: 1. patients are at high risk of hcc. 2. the ages of patients are between 18 and 80. 3. patients are with solid liver lesion(s) ≤ 2 cm detected by imaging scan (us/ct/mri). 4. the number of lesions is less than or equal to 3. 5. patient is able and willing to receive ceus and eob-mri examinations within 30 days. 6. patient signs the informed consent. exclusion criteria: 1. patient is with lesions confirmed by pathology or follow-up, or hemangiomas. 2. patient is with lesions already undergoing local treatment, including thermal ablation or tace. 3. patient is with severe cardiopulmonary insufficiency. 4. patient is a pregnant or breastfeeding women. 5. patient is considered to be unsuitable to participate in the study.

Keywords: hepatocellular cancer contrast-enhanced ultrasound eob-mri diagnostic efficacy
fully automated pipeline for the detection and segmentation of non-small cell lung cancer (nsclc) on ct images

Conditions: Detection; Segmentation

Summary: accurate segmentation of lung tumor is essential for treatment planning, as well as for monitoring response to therapy. it is well-known that segmentation of the lung tumour by different radiologists gives different results (inter-observer variance). moreover, if the same radiologist is asked to repeat the segmentation after several weeks, these two segmentations are not identical (intra-observer variance). in this study we aim to develop an automated pipeline that can produce swift, accurate and reproducible lung tumor segmentations.

in this study, we aim to develop and test an automated deep learning detection and segmentation software for non-small cell lung cancer (nsclc) that can automatically detect and segment tumors on ct scans and thus reduce the human variation. we will assess the level of agreement between a group of radiologists, performing manual versus semi-automatic tumour segmentation. to do so, we will provide radiologists with two sets of ct scans. the first set will be segmented manually; the second one will be segmented using the automated software program. subsequently, we will use the inter- and intra-observer variance from the clinical study in a simulation or modeling study. we also compare the time needed and the consistency in segmentations by the software to medical doctors performance. reliability and agreement study: primary tumours of 25 lung cancer patients will be delineated by 6 segmentation experts. 1. assess agreement between automatic segmentation and radiologists' segmentation the primary tumours of 25 patients will be manually segmented by the radiologists and automatically by the the tool. the time needed to perform this task and the reproducibility of the segmentation will be recorded. the degree of overlap between the ros and the automatic contour will be assessed pairwise using the dice coefficient. 2. delination of tumours by the experts, assisted by the software tool for another 25 patients, the experts will be provided with an automatic delineation, performed by the tool. they have the possibility to adjust and validate it. the time needed will be recorded. the difference between the mean overlap fraction in the first situation (manual delineation of experts) and the second situation (delineation of experts+ software tool) will be assessed, using a multi-observer dice coefficient. 3. assessment of intra-observer variance the experts will repeat the segmentation of the lung tumours after 2 weeks. they will repeat the manual segmentation (n=25) and the semi-automatic segmentation (n=25). this will make it possible to assess the intra-observer variance in both situations. 4. qualitative assessment of the experts' preferences using an in-house developed visualization toolbox.

Eligibility criteria:
inclusion criteria: * availability of ct scans * availability of definite diagnosis exclusion criteria: * lack of segmentations
ivig therapy for patients with idiopathic cardiomyopathy and endomyocardial biopsy proven high pvb19 viral load

Conditions: Heart Failure

Summary: rationale: parvovirus b19 (pvb19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to dilated cardiomyopathy. objective: whether high dose of intravenous immunoglobulin (ivig) in addition to conventional heart failure therapy achieves virus reduction, thereby resulting in improvement of cardiac function. study design: a interventional study of virus presence and cardiac functional capacity before and after ivig therapy. study population: patients with idiopathic cardiomyopathy and symptomatic heart failure for more than 1 year and a significant pvb19 viral load in endomyocardial biopsies (emb) and treated with high dose of ivig were included. intervention (if applicable): patients were treated with a total dose of 2 g/kg of immune globulin administered as 0.5 g/kg iv over a period of 6 hours on each of 4 consecutive days. main study parameters/endpoints: embs: virus (pvb19, enteroviruses, adenoviruses, epstein-barr virus, human herpes virus-6 and cytomegalovirus), inflammation (lymphocytes an macrophages) and fibrosis. cardiac functional capacity: nyha classification, echocardiographic evaluation (left ventricular ejection fraction, end-systolic diameter, end-diastolic diameter).


Eligibility criteria:
inclusion criteria: * idiopathic heart failure \<1 year. * optimal conventional heart failure medication \<6 months. * pvb19 viral load \>150copies/mcg dna in embs. exclusion criteria: * significant (lesions \>50% stenosis) coronary artery disease. * significant valvular disease. * systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases.

Keywords: heart failure parvovirus b19 intravenous immuneglobulin
long-term follow-up of antithrombotic management patterns in acute coronary syndrome patients in asia

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to describe the short-and long-tern (i.e. up to 2 years following the index event) amps in patients hospitalized for an acute coronary syndrome (i.e. stemi or nste-acs), and to document clinical outcomes, economic aspects and impact on quality of life of these amps in a 'real-life' setting.


Eligibility criteria:
inclusion criteria: * written informed consent has been provided. * diagnosis of stemi, nstemi or ua * hospitalization for the first time within 48 hours of onset of symptoms. exclusion criteria: * ua, stemi, nstemi precipitated by or as a complication of surgery, trauma, or gi bleeding or post-pci ua, stemi and nstemi occurring in patients already hospitalized for other reasons. * current participation in a randomised interventional clinical trial.

Keywords: long-term follow up antithrombotic management patterns acute coronary syndrome asia quality of life
manual therapy for the treatment of athletic pubalgia

Conditions: Osteitis Pubis

Summary: athletic osteitis pubis is a high prevalent pathology among athletes, especially in those who make quick change of direction of the movement, like runners or footballers. despite the fact that there is evidence about conservative treatments, there is a lack of evidence about manual therapy (mt) techniques applied in isolation and its consequences in pain and range of movement. the investigators decided to conduct a randomized controlled trial to compare the effects of a mt technique with placebo technique.


Eligibility criteria:
inclusion criteria: * athletes diagnosed with osteitis pubis stage 1 with at least 3 months of evolution. * internal rotation rom limited. * positive provocation pain tests. exclusion criteria: * pain due to intraarticular hip pathology. * hip pain due to inflamatory diseases. * previous surgical interventions in hip, pelvis or lumbar spine. * mri results or provocation pain tests inconcluyent.
palonosetron associated to aprepitant in prophylaxis of ponv

Conditions: Postoperative Nausea and Vomiting

Summary: the objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of ponv in high-risk patients for this symptom, undergoing cancer surgery mastectomies.

postoperative nausea and vomiting (ponv) is a common anesthetic complication that occurs in approximately 30% of the surgical population and can reach up to 70% in high risk patients for ponv. advances have been made to prevent ponv, but the incidence is still high in certain groups of patients. in high risk patients, pharmacologic intervention should consist of multimodal therapy, targeting different mechanisms of action. the objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of ponv in high-risk patients for this symptom, undergoing cancer surgery mastectomies. methods: this is a randomized and double blind clinical trial. female high-risk patients for ponv(apfel score 3 or 4) scheduled for mastectomy that agree with the study and signed the informed consent, are randomly distributed into one of two groups: group a, aprepitant 80 mg per os one hour before the surgery and group b will receive placebo by the same route one hour before surgery, in a blinded way. after induction of anesthesia, dexamethasone 4 mg and palonosetron 0,075mg are intravenously administered to all patients. after the end of the surgery, a patient-controlled analgesia (pca) device will be intravenously inserted in all patients. in the postoperative period, patients will be evaluated for nausea, vomiting and pain intensity in the recovery room and after 24 hours

Eligibility criteria:
inclusion criteria: * patients submitted to breast cancer surgery * non smokers exclusion criteria: * any contraindication to one of the drugs * mental disease * inability to understand the method or refusal to participate in the research

Keywords: nausea and vomiting, postoperative emesis, postoperative